MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® INLAY® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE

Model Number 777626

Device Problem Biocompatibility (2886)

Patient Problems Dyspnea (1816); Pain (1994); Tachycardia (2095); Discomfort (2330)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the patient was admitted to the hospital for treatment of right kidney stone with hydronephrosis.After admitted, the doctor placed a ureteral stent for the patient to assist in urination, according to the condition of the patient.The patient experienced pain, discomfort accompanied by palpitations and tightness of breath, after the ureteral stent was inserted and the doctor stopped placing the stent and pulled it out.At the same time, oxygen was inhaled, and the vital signs were detected by echocardiogram monitoring.The patient reported relief of pain symptoms, no palpitations, and no tightness of breath.

Event Description

It was reported that a patient was admitted to the hospital for treatment of "right kidney stone with hydronephrosis.After admitted, the doctor placed a ureteral stent for the patient to assist in urination on october 28th, according to the condition of the patient.The patient experienced pain, discomfort accompanied by palpitations and tightness of breath, after the ureteral stent was inserted and they doctor stopped placing the stent and pulled it out.At the same time, oxygen was inhaled and the vital signs were detected by echocardiogram monitoring.The patient reported relief of pain symptoms, no palpitations, and no tightness of breath.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.The device was used for treatment, it is unknown if the device had met product specifications or contributed to the reported event.A potential root cause for this event could be, "material selection".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "the insertion of a ureteral stent should only be done by those individuals who have comprehensive training in the techniques and risks of the procedure." potential complications associated with retrograde/antegrade positioning of indwelling ureteral stents include the following: edema, stone formation, peritonitis, extravasation, ureteral reflux, stent dislodgement, fragmentation, migration, occlusion, fistula formation, loss of renal function, hemorrhage, pain/discomfort, stent encrustation, hydronephrosis, perforation of kidney, renal, ureteral erosion, infection pelvis, ureter and/or bladder urinary symptoms determine the proper stent length for the patient.This is generally calculated from the baseline pyelogram.Accurate measurements will optimize drainage effi ciency and patient comfort.Submerge stent in sterile water to activate the coating." h11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.

• Brand Name: BARD® INLAY® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
• Type of Device: URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12459157
• MDR Text Key: 270989980
• Report Number: 1018233-2021-05593
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741014557
• UDI-Public: (01)10801741014557
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K983498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 777626
• Device Catalogue Number: 777626
• Device Lot Number: NGCZ3367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male